30 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALCON ULTRACHOPPER
FDA 510(k)
FDA Class 2
·Ophthalmic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450298237·
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 13, 2026
PANORAMA CENTRAL STATION
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 28, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·May 17, 2011
UNIVERSA SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·September 25, 2018
UNIVERSA SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·September 26, 2018
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZN·April 7, 2017
UNIVERSA SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·July 8, 2019
UNIVERSA SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·November 14, 2017
UNIVERSA SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·November 19, 2018
UNIVERSA SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·July 19, 2018
UNIVERSA SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·August 1, 2018
UNIVERSA SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·August 22, 2018
UNIVERSA SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·February 21, 2018
UNIVERSA SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·January 25, 2018